Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Prevalence of type 2 diabetes mellitus
研究概览
简要总结
Gestational diabetes mellitus (GDM) is the most common complication and metabolic disorder during pregnancy, with clear risks to both the mother and fetus. In recent years, the long-term chronic diseases and poor prognosis in GDM women after delivery, as well as the risk of obesity and metabolic disorders in their offspring, have become key research topics. However, due to the long duration of GDM's impact on both the mother and offspring and its involvement in multiple disciplines, high-quality cohort studies are scarce. As a result, there is no definitive conclusion regarding the high-risk factors, natural progression, key mediators, timing of interventions, and targets for GDM's long-term effects on mothers and their offspring. This project intends to initiate a prospective follow-up study, establish a specialized cohort for the long-term effects of GDM on both mothers and their offspring, and complete the characterization of the natural course of non-communicable chronic diseases (NCDs) in GDM women and their offspring. The study will also explore high-risk and mediator factors, and develop predictive models. The goal is to provide education, postpartum follow-up, monitoring, and possibly initiate primary prevention for GDM women to reduce the long-term NCD risks, ultimately improving their life expectancy and providing a theoretical basis for intervention.
Inclusion Criteria:
- Adult patients (≥18 years old) who registered for antenatal care and delivered at Peking University Firest Hospital's obstetrics department between 2007 and 2016.
- Diagnosed with gestational diabetes mellitus (GDM) during pregnancy via an oral glucose tolerance test (OGTT).
- Signed informed consent.
Exclusion Criteria:
- Lack of pregnancy-related obstetric follow-up records.
- Inability to cooperate with and complete subsequent scheduled follow-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old) who registered for antenatal care and delivered at Peking University Firest Hospital's obstetrics department between 2007 and
- •Diagnosed with gestational diabetes mellitus (GDM) during pregnancy via an oral glucose tolerance test (OGTT).
- •Signed informed consent.
排除标准
- •Lack of pregnancy-related obstetric follow-up records.
- •Inability to cooperate with and complete subsequent scheduled follow-ups.
结局指标
主要结局
Prevalence of type 2 diabetes mellitus
时间窗: At 8-17 years postpartum
Subjects who meet either criterion 1 or 2 will be considered to have type 2 diabetes： 1. With classical symptoms of diabetes: if any one of the following is met: Random plasma glucose ≥ 11.1 mmol/L, or Fasting plasma glucose (FPG) ≥ 7.0 mmol/L, or 2-hour plasma glucose during an oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L, or HbA1c (glycated hemoglobin) ≥ 6.5%. 2. Without classical symptoms of diabetes: either two glucose indicators measured at the same time point reaching or exceeding diagnostic thresholds, or Glucose indicators measured at two different time points reaching or exceeding diagnostic thresholds (excluding random plasma glucose).
Prevalence of metabolic syndrome
时间窗: At 8-17 years postpartum
Individuals meeting 3 or more of the following 5 components will be considered to have metabolic syndrome: 1. Waist circumference ≥ 85 cm in women; 2. FPG ≥ 6.1 mmol/L and/or 2hPG ≥ 7.8 mmol/L, and/or previously diagnosed diabetes; 3. Blood pressure ≥ 130/85 mmHg, and/or previously diagnosed hypertension and treated; 4. Fasting TG ≥ 1.7 mmol/L; 5. Fasting HDL-C \< 1.04 mmol/L.
Prevalence of cardiovascular diseases
时间窗: At 8-17 years postpartum
The presence of any of the following items is considered indicative of cardiovascular disease: 1. Inquire about history(definitively diagnosed by a qualified physician) of cardiovascular diseases, including coronary heart disease, hypertension and arrhythmia. 2. Quantify coronary artery calcium score via non-contrast CT scan, \> 100 indicates elevated risk for coronary heart disease. 3. With Framingham Cardiovascular Risk Score calculated for non-diseased individuals(men ≥15 and women ≥18 are classified as high cardiovascular risk). 4. Perform an electrocardiogram for diagnose of arrhythmia. 5. ABI, TBI, and baPWV are utilized to assess arteriosclerosis in the extremities, ABI \< 0.9 or TBI \< 0.7 or baPWV \> 1400 cm/s is diagnostic of peripheral arterial disease. 6. Carotid ultrasonography is performed to assess carotid plaque.
Prevalence of cognitive function
时间窗: At 8-17 years postpartum
Inquire about history of cognitive function(definitively diagnosed by a qualified physician).
Prevalence of renal disease
时间窗: At 8-17 years postpartum
Subjects who meet criterion 1 or 2 will be considered to have renal disease: 1. Serum creatinine\>133μmol/L. 2. Urinary microalbumin/urinary creatinine\>30mg/g.
次要结局
- Prevalence of depression(At 8-17 years postpartum)
- Hyperuricemia(At 8-17 years postpartum)
- Offspring Growth and Development(At 8-17 years old)
- Hyperhomocysteinemia(At 8-17 years postpartum)
- Fatty liver disease(At 8-17 years postpartum)
- Prevalence of anxiety(At 8-17 years postpartum)
- CAIDE Dementia Risk Score(At 8-17 years postpartum)
- N-acetyl-β-D-glucosaminidase (NAG)(At 8-17 years postpartum)
- Thyroid Function(At 8-17 years postpartum)
- Bone Density(At 8-17 years postpartum)
- Body fat percentage:(At 8-17 years postpartum)
- Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)(10-18 years old)
- Social Anxiety Scale for Children (SASC)(10-18 years old)
- Kutcher Adolescent Depression Scale (11-item version, KADS-11)(11-17 years old)
- Screen for Child Anxiety Related Emotional Disorders (SCARED)(10-18 years old)
研究者
Yang ZHANG
Associated chief of the endocrinology department of peking university first hospital
Peking University First Hospital